A Critical Study of Access to Medicines in Light of Indian Patent (Amendment) Act, 2005

Abstract

Indian Patent Act,1970 was the law governing patents before the formulation of the TRIPS agreement. The subject matter of patentability according to this legislation was the process of making chemicals, drugs and medicines which lead to the emergence of many domestic drug manufacturers who produced new drugs by way of reverse engineering. Indian drug market was considered as the cheapest drug manufacturers and the cost of medicines was affordable by people of every income group. The TRIPS agreement, 1995 was signed by India and major changes were incorporated in the Indian Patents Act, 1970 through various amendments. Before the TRIPS agreement was signed Indian patent regime was focussed on process patents because of which generic market flourished, but by way of the 2005 Amendment to the Patents Act, patents on food, chemical and pharmaceuticals were includes as product patents. This change proposed by the TRIPS was a major blow to the generic market of pharmaceutical manufacturers as they could no longer manufacture drugs by reverse engineering and created monopoly over the patent owners of the drugs. Another major change suggested by the TRIPS agreement was a result of the Doha Declaration, 2002 which was with the objective to strike a balance between the interests of the Patent owner and to ensure access to medicines at affordable prices. The Patents (Amendment)Act, 2002 was an attempt to establish this balance by implementing the principle of compulsory licensing. This principle was laid down in Article 30 of the Agreement that allowed the Member states to legislate compulsory licensing provisions. In the Indian Patent Act,1970 the compulsory licenses can be granted only after 3 years of patent except in case of national emergency or when reasonable requirements of the public are not satisfied etc as per the provisions of Section 84 of the Act. Even though the TRIPS agreement is exhaustive about the balance between the economic interest and the public health, the Indian legislation has failed to specify what circumstances would be considered to be “reasonable requirements of the public”, the procedural requirements are onerous and result in delay, patents result in monopolistic control of the pharmaceuticals and lead to anti-competitive practices. Another lacuna in effective implementation of compulsory licensing is the payment of remuneration to the original patent owner and there is no rate of payment of remuneration and it is left to the discretion of the parties at that time which may be unreasonable if the demand is too high and the government in need is not able to make the payment. The scope of this topic is to critically analyse the limitations and exceptions in the TRIPS agreement with respect to pharmaceutical industry and the effective application of these exceptions to fulfil the objective of striking a balance between the public health and protecting the interest of the patent owner. This dissertation will also discuss about the compulsory licensing procedure adopted in the Indian Patent Act, the impact on the generic manufacturer after TRIPS agreement , the changes in the pharmaceutical industry and the impact of these changes on small pharmaceutical companies at par with the large pharmaceutical companies and give suggestions for better implementation to achieve the objective of Doha Declaration.